November 17, 2009

Questions for Small Entity Representatives

Small Business Advocacy Review Panel on Insect Repellents: Reconsideration of Exemption; Revising the Minimum Risk Pesticide Exemption to Remove Skin-Applied Insect Repellents

For each of the approaches under discussion, plea se let us know of any alternate solutions that provide flexibility or decrease econo mic impact for small entities while still accomplishing the stated goal.

In your written comments after our discussion, please also consider including answers to the questions below. Your feedback to this Panel is not limited to the questions in this document.

Tips for most effective comments :

• We are interested in as much informa tion as you can provide. Providing examples or reasons for why you think an approach won’t work is more helpful than just stating that it is a bad idea.

• Be specific on why an approach would be difficult or burdensome for you.

• Suggest detailed alternatives you th ink would meet the criteria.

• Your detailed input on cost can help us choose the most cost-effective options.

Questions: Costs and regulations

1. How much would each approach we desc ribed cost you? Please break down any cost estimates into:

• Monetary estimates

• Time (including whose time, e.g. cl erical, technical, managerial, owner)

• Materials 2. Do you have suggestions for how these a pproaches could be modified to be more workable for your company? Do you have suggestions for entirely alternate approaches?

• In what ways would these modificati ons or alternativ es help? (Lower cost, less complicated process, etc)

• Please estimate the costs of any modifications or alternative approaches. 3. Do you have information we should consider regarding non-regulatory approaches? 4. Please describe how you currently test your skin-applied insect repellent products.

• Toxicity

• Efficacy

• What are the costs associated with those tests?

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5. Letting required changes to labels take place over a long period of time can sometimes reduce the cost of those changes.

• If the labels for your product(s) were required to change, what timeframe for implementing this would have the lowest cost?

• What would that cost be?

• If that timeframe was shortened, how much would the cost to your company increase?

Questions: Insect repellen ts and other pesticides

6. Do you produce or sell other minimum-risk pesticides (such as products for use in lawns, gardens, or homes, products for use on pets/animals, etc)? 7. Do you produce or sell:

• Any pesticides regist ered with EPA?

• Any skin-applied insect repellen ts registered with EPA?

• If not currently, have yo u in the past registered pesticides with EPA? 8. Regarding minimum-risk, skin-applied insect repellents, what does your company do?

• Manufacture

• Repackage

• Distribute

• Market

• Wholesale

• Retail sale / direct to consumer sales

• Other 9. How many minimum-risk, skin-applied in sect repellent pr oducts does your company have? 10. What portion of your company’s reve nue or income is derived from minimum-risk, skin-applied insect repellents? 11. Can you provide us with copies of labels from your skin-applied insectrepellent products? 12. Does your company provide any non-pest icide products or services? If so, please describe them.

Questions: Small entities

13. Would a specific flexibility for small entities be useful to you?

• Examples: more time to comply with requirements, more streamlined process, assistance with understanding requirements

• Please be specific with suggested alte rnatives and why the flexibility is needed for small entities (and not for larger firms). 14. What criteria should be used to define a small entity eligible for flexibility?

• Revenue? Number of empl oyees? Other criteria?

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• Please suggest a number in the category you choose, and any information that can support your choice.

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